Fluid collection systems including at least one tensioning element

ABSTRACT

Embodiments disclosed herein are directed to fluid collection systems and methods of using the same. An example fluid collection system includes a fluid collection assembly and at least one tensioning element (e.g., wire). The fluid collection assembly includes a fluid impermeable barrier that defines at least a chamber and at least one porous material disposed in the chamber. The tensioning element of the fluid collection system is configured to switch from a relaxed state and a tensioned state. The tensioning element is in the relaxed state when substantially no external tensile force is applied thereto and the tensioned state when an external tensile force is applied thereto. The tensioning element is configured to change a curvature of at least a portion of the fluid collection assembly, for example, by switching the tensioning element between the relaxed state and the tensioned state.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application claims priority to U.S. Provisional Patent ApplicationNo. 63/008,511 filed on Oct. 7, 2020, the disclosure of which isincorporated herein, in its entirety, by this reference.

BACKGROUND

A person or animal may have limited or impaired mobility such thattypical urination processes are challenging or impossible. For example,a person may experience or have a disability that impairs mobility. Aperson may have restricted travel conditions such as those experiencedby pilots, drivers, and workers in hazardous areas. Additionally,sometimes urine collection is needed for monitoring purposes or clinicaltesting.

Urinary catheters, such as a Foley catheter, can be used to address someof these circumstances, such as incontinence. Unfortunately, urinarycatheters can be uncomfortable, painful, and can lead to complications,such as infections. Additionally, bed pans, which are receptacles usedfor the toileting of bedridden patients are sometimes used. However,bedpans can be prone to discomfort, spills, and other hygiene issues.

SUMMARY

Embodiments disclosed herein are directed to fluid collection systemsand methods of using the same. In an embodiment, a fluid collectionsystem is disclosed. The fluid collection system includes a fluidcollection assembly. The fluid collection assembly includes a fluidimpermeable barrier defining a chamber, at least one opening, and atleast one fluid outlet. The fluid collection assembly also includes tleast one porous material disposed in the chamber. The fluid collectionsystem also includes at least one tensioning element at least partiallydisposed in the fluid collection assembly. The at least one tensioningelement is configured to switch from a relaxed state when the at leastone tensioning element has substantially no tension force appliedthereto and a tensioned state when the at least one tensioning elementhas a tension force applied thereto. Switching the at least onetensioning element between the relaxed state and the tensioned statechanges a curvature of at least a portion of the fluid collectionassembly.

In an embodiment, a method of using a fluid collection system. Themethod includes positioning at least one opening of a fluid collectionassembly adjacent to a female urethral opening. The fluid collectionassembly includes a fluid impermeable barrier defining a chamber, atleast one opening, and at least one fluid outlet. The fluid collectionassembly also includes at least one porous material disposed in thechamber. The fluid collection system further comprises at least onetensioning element at least partially disposed in the fluid collectionassembly. The method also includes tensioning at least one tensioningelement to switch the tensioning element from a relaxed state to atensioned state to change a curvature of the fluid collection assembly.

Features from any of the disclosed embodiments may be used incombination with one another, without limitation. In addition, otherfeatures and advantages of the present disclosure will become apparentto those of ordinary skill in the art through consideration of thefollowing detailed description and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate several embodiments of the present disclosure,wherein identical reference numerals refer to identical or similarelements or features in different views or embodiments shown in thedrawings.

FIGS. 1A and 1B are isometric views of a fluid collection system thatincludes a fluid collection assembly in a first shape and a secondshape, respectively, according to an embodiment.

FIGS. 1C and 1D are cross-sectional schematics of the fluid collectionassembly taken along planes C-C and D-D shown in FIG. 1A, respectively.

FIGS. 2A-2E are cross-sectional schematics of fluid collection systemshaving at least one tensioning element positioned at different locationsof the fluid collection assembly, according to different embodiments.

FIG. 3 is a schematic cross-sectional schematic of a fluid collectionsystem, according to an embodiment.

FIGS. 4A-4C are isometric views of different locking devices that may beused in any of the fluid collection systems disclosed herein, accordingto different embodiments.

FIG. 5 is a block diagram of a system for fluid collection, according toan embodiment.

FIG. 6 is a flow diagram of a method to collect fluid, according to anembodiment.

DETAILED DESCRIPTION

Embodiments disclosed herein are directed to fluid collection systemsand methods of using the same. An example fluid collection systemincludes a fluid collection assembly and at least one tensioning element(e.g., wire). The fluid collection assembly includes a fluid impermeablebarrier that defines at least a chamber, at least one opening, and atleast one fluid outlet. The fluid collection assembly also includes atleast one porous material disposed in the chamber. The at least onetensioning element of the fluid collection system is configured toswitch from a relaxed state and a tensioned state. The at least onetensioning element is in the relaxed state when substantially noexternal tensile force is applied thereto and the tensioned state whenan external tensile force is applied thereto. The at least onetensioning element is configured to change a curvature of at least aportion of the fluid collection assembly, for example, by switching thetensioning element between the relaxed state and the tensioned state.

During use, the fluid collection assembly is positioned adjacent to aurethral opening (e.g., vagina) of the patient. One or more bodilyfluids (e.g., urine, blood, etc.) that are discharged from the urethralopening of the patient flow through the opening and into the chamber.The bodily fluids that enter the chamber are received into the porousmaterial and are directed towards the fluid outlet. The bodily fluidsmay be removed from the chamber through the fluid outlet, for example,when a suction force from a vacuum source is applied to the fluidoutlet.

Generally, the fluid collection assembly conforms to the shape of theregion about the urethral opening to prevent gaps between the fluidcollection assembly and the region about the urethral opening. Forexample, bodily fluids may leak (e.g., do not enter the chamber and/ordo not remain in the chamber) through gaps between the fluid collectionassembly and the region about the patient. Such leaks may beembarrassing to the patient using the fluid collection assembly, causethe skin of the patient to remain moist which may cause skin degradation(e.g., rash) and general discomfort, and create unsanitary situations.

The region of the patient about the urethral opening may vary in sizeand shape depending on the patient. Some conventional fluid collectionassemblies are manually bent to conform to the shape of the region aboutthe urethral opening to prevent gaps between the conventional fluidcollection assemblies and the region about the patient. Contact betweenthe thighs of the patient and the conventional fluid collectionassemblies maintains the bent form of the conventional fluid collectionassemblies. However, relatively thin or skinny patients may have toosmall of thighs to maintain contact with the conventional fluidcollection assemblies while forgetful patients (e.g., confused patients,young children, patients with dementia) may move their legs such thatthe thighs no longer contact the conventional fluid collectionassemblies, either of which may cause the conventional fluid collectionassembly to lose the bent shape thereof.

Embodiments of fluid collection systems disclosed herein (e.g., fluidcollection assemblies including at least one tensioning element) amountto an improvement to systems that include such conventional fluidcollection assemblies. As previously discussed, the fluid collectionsystems disclosed herein include at least one tensioning element. The atleast one tensioning element is configured to control the curvature ofat least a portion of the fluid collection assembly such that at least aportion of the fluid collection generally conforms to the shape (e.g.,curvature) of the region about the urethral opening. The at least onetensioning element may also allow the fluid collection assembly tomaintain the shape thereof without relying on contact between the fluidcollection assembly and the thighs of the patient. As such, the at leastone tensioning element may minimize gaps between the fluid impermeablebarrier and the region about the urethral opening through which bodilyfluids may flow.

At least a portion of the at least one tensioning element may bedisposed in the fluid collection assembly. The fluid collection assemblymay exhibit a first (e.g., initial) shape when the tensioning element isin the relaxed state. The at least one tensioning element may have anexternal tensile force applied thereto to switch the tensioning elementto the tensioned state thereof. The tensile force applied to the atleast one tensioning element may cause the at least one tensioningelement to apply a compressive force to the portions of the fluidcollection assembly thereabout. The compressive force decreases a lengthof the portions of the fluid collection assembly adjacent to the atleast one tensioning element while the portions of the fluid collectionassembly that are spaced from the at least one tensioning element mayexhibit no length change or a smaller length change than the portions ofthe fluid collection assembly adjacent to the at least one tensioningelement. The decreased length of the portions of the fluid collectionassembly adjacent to the at least one tensioning element may cause thefluid collection assembly to bend such that the fluid collectionassembly exhibits a second shape that is different than the first shape.In an example, the first shape of the fluid collection assembly mayexhibit a straight or substantially straight shape when the at least onetensioning element is in the relaxed state. In such an example, applyinga tensile force to the at least one tensioning element may cause thefluid collection assembly to exhibit a bent shape. In an example, thefluid collection assembly may exhibit a curved shape when the at leastone tensioning element is in the relaxed state. In such an example,applying a tensile force to the at least one tensioning element mayincrease the curvature of the fluid collection assembly or maystraighten the fluid collection assembly

FIGS. 1A and 1B are isometric view of a fluid collection system 100 thatincludes a fluid collection assembly 101 in a first shape and a secondshape, respectively, according to an embodiment. FIGS. 1C and 1D arecross-sectional schematics of the fluid collection assembly 101 takenalong planes C-C and D-D shown in FIG. 1A, respectively. The fluidcollection assembly 101 include a fluid impermeable barrier 102. Thefluid impermeable barrier 102 includes a proximal surface 104 that isconfigured to be positioned adjacent to an patient during use and adistal surface 106 opposite the proximal surface 104. The fluidimpermeable barrier 102 defines at least a chamber 108, at least oneopening 110 that is defined by the proximal surface 104, and at leastone fluid outlet 112. The fluid collection assembly 101 also includes atleast one porous material 114 disposed in the chamber 108. The fluidcollection system 100 also includes at least one tensioning element 116.At least a portion of the tensioning element 116 is disposed in thefluid collection assembly 101.

The tensioning element 116 is a longitudinally extending element thatmay be at least partially disposed in the fluid collection assembly 101.The tensioning element 116 may include, for example, at least one wire,at least one sheet, at least one thread, a monofilament, a plurality ofmonofilaments (e.g., a plurality of monofilaments twisted or braidedtogether), a rope or thread, combinations of the foregoing, any otherdevice that may have a tensile force applied thereto. Generally, thetensioning element 116 is flexible, which allows the tensioning element116 to conform to the shape of the fluid collection assembly 101 whenthe tensioning element 116 is in the relaxed state and the exhibit ashape change when switching between the relaxed and tensioned states.For example, the tensioning element 116 may be formed from a fabric, apolymer (e.g., polyethylene, polypropylene, polyvinyl chloride, etc.), athin metal wire, a composite, or combinations thereof. In some examples(as shown in FIGS. 2A-2C), the tensioning element 116 may be exposed tothe bodily fluids that are present in the chamber 108. In such examples,the tensioning element 116 may be formed from a material that isresistant to the bodily fluids or coated with a material that isresistant to the bodily fluids. Examples of material that are resistantto the bodily fluids may include oxidation resistant materials or otherchemically inert materials. For instance, when the tensioning element116 is not formed from a material that is resistant to the bodilyfluids, the bodily fluids may cause the tensioning element 116 torelease contaminants (e.g., ions, micro-particles) into the bodilyfluids. Backflow of the bodily fluids may cause the contaminants to comein contact with and irritate the skin of the individual.

The tensioning element 116 includes an fixed portion 126 (shown in FIG.1D) that is fixedly secured to one or more components of the fluidcollection assembly 101, such as the fluid impermeable barrier 102, theporous material 114, or the conduit 128. In an example, as illustrated,the fixed portion 126 is at the terminal end of the tensioning element116. In an example, the fixed portion 126 may be spaced from theterminal end of the tensioning element 116. In such an example, thefixed portion 126 is generally near (e.g., within about 1 mm, withinabout 2.5 mm, within about 5 mm, or within about 1 cm) of the terminalend of the tensioning element 116 since any portion of the tensioningelement 116 between the terminal end and the fixed portion 126 may beextraneous (e.g., may be unable to switch between relaxed and tensionedstates). The fixed portion 126 is configured to maintain a positionthereof relative to the component to which it is attached when a tensileforce is applied to the tensioning element 116. For example, the fixedportion 126 allows a tensile force to be applied to the tensioningelement 116 when tensioning element 116 is pulled on since the fixedportion 126 acts as an anchor.

The component to which the fixed portion 126 is attached may be selectedto be a component of the fluid collection assembly 101 to which theterminal end of the tensioning element 116 is adjacent. For example, inthe illustrated embodiment, at least a portion of the tensioning element116 is within the fluid impermeable barrier 102 and, unless thetensioning element 116 moves out of the fluid impermeable barrier 102,the fixed portion 126 is attached to the fluid impermeable barrier 102.Alternatively, the fixed portion 126 may be attached to the fluidimpermeable barrier 102 and/or the porous material 114 when at least aportion of the tensioning element 116 is between the fluid impermeablebarrier 102 and the porous material 114 (FIG. 2A), attached to theporous material 114 when at least a portion of the tensioning element116 is disposed within the porous material 114 (FIG. 2B), attached tothe porous material 114 and/or the conduit 128 when at least a portionof the tensioning element 116 is between the porous material 114 and theconduit 128 (FIG. 2C), or attached to the conduit 128 when at least aportion of the conduit is positioned within the conduit 128 (FIGS. 2Dand 2E). The fixed portion 126 may be attached to the component of thefluid collection assembly 101 using any suitable attachment technique,such as via an adhesive, welding (e.g., ultrasonic welding), tape,crimping, or a knot.

As previously discussed, the tensioning element 116 is configured toswitch between a relaxed state and a tensioned state. The tensioningelement 116 switches from the relaxed state to the tensioned state byapplying an external tensile force to the tensioning element 116. Thetensile force may be applied to the tensioning element 116 by pulling onportions of the tensioning element 116 that are not disposed within thefluid collection assembly 101. The tensioning element 116 may switchfrom the tensioned state to a relaxed state by removing the tensileforce form the tensioning element 116.

Switching the tensioning element 116 between the relaxed state and thetensioned state is configured to change the shape of the fluidcollection assembly 101. For example, switching the tensioning element116 from the relaxed state to the tensioned state causes the tensioningelement 116 to apply a greater compressive force on a first portion ofthe fluid collection assembly 101 than a second portion of the fluidcollection assembly. As used herein, the first portion of the fluidcollection assembly 101 refers to a portion of the fluid collectionassembly 101 adjacent to the tensioning element 116 and the secondportion of the fluid collection assembly 101 refers to a portion of thefluid collection assembly 101 that is spaced from the tensioning element116. For example, the tensile force may cause the fixed portion 126 ofthe tensioning element 116 to pull the component to which it is attachedin a direction that is parallel to the tensile force. Pulling thecomponent in such a manner applies a compressive force to first portionthe fluid collection assembly 101. The compressive force causes a lengthof the first portion of the fluid collection assembly to decrease whilea length of the second portion of the fluid collection assembly remainsthe same or decrease at a rate that is less than the first portion. Thedifferent changes of length between the first and second portions of thefluid collection assembly 101 causes the shape of the fluid collectionassembly 101 to change. For example, the decreased length change of thefirst portion relative to the second portion causes the fluid collectionassembly 101 to bend towards the first portion. Switching the tensioningelement 116 from the tensioned state to the relaxed state causes thelengths of the first and second portions to generally return to theiroriginal lengths. In other words, the length of the first portionincreases more than the second portion when the tensioning element 116switches from the tensioned state to the relaxed state thereby returningthe fluid collection assembly to its original shape.

The amount of the tensioning element 116 changes the shape of the fluidcollection assembly 101 may be controlled based on the magnitude of thetensile force applied to the tensioning element 116. For example,increasing the tensile force to the tensioning element 116 may cause thefluid collection assembly 101 to deviate more from the first (e.g.,initial) shape that the fluid collection assembly 101 exhibits when thetensioning element 116 is in the relaxed state. Further, decreasing thetensile force to the tensioning element 116 may cause the fluidcollection assembly 101 to deviate less from the first shape.

The position of the tensioning element 116 in the fluid collectionassembly 101 may at least partially dictate how the tensioning element116 changes the shape of the fluid collection assembly 101 when thetensioning element 116 switches between the relaxed and tensioned statesthereof. In other words, the position of the tensioning element 116 inthe fluid collection assembly 101 at least partially dictates whichportions of the fluid collection assembly 101 are the first portion andthe second portion. Generally, the tensioning element 116 issubstantially centered between the lateral surfaces 130 of the fluidimpermeable barrier 102 that extend between the proximal and distalsurfaces 104, 106 of the fluid impermeable barrier 102. This ensuresthat the opening 110 may extend along the vagina instead of bending tothe side when the tensioning element 116 in the tensioned state.However, the tensioning element 116 may be positioned closer to theproximal surface 104 or the distal surface 106. In an embodiment, asillustrated, the tensioning element 116 is positioned closer to theproximal surface 104 than the distal surface 106. In such an embodiment,the first portion of the fluid collection assembly 101 is closer to theproximal surface 104 than the second portion while the second portion iscloser to the distal surface 106 than the first portion. As such, whenthe tensioning element 116 is closer to the proximal surface 104,switching the tensioning element 116 from the relaxed state to atensioned state causes the fluid collection assembly 101 to bend towardsthe proximal surface 104. Referring to FIGS. 1A and 1B, when thetensioning element 116 is closer to the proximal surface 104, thetensioning element 116 is in a relaxed state when the fluid collectionassembly 101 exhibits the first shape (FIG. 1A) and in a tensioned statewhen the fluid collection assembly 101 exhibits the second shape (FIG.1B). In an embodiment, not shown, the tensioning element 116 ispositioned closer to the distal surface 106 than the proximal surface104. In such an embodiment, the first portion of the fluid collectionassembly 101 is closer to the distal surface 106 than the second portionwhile the second portion is closer to the proximal surface 104 than thefirst portion. As such, when the tensioning element 116 is closer to thedistal surface, switching the tensioning element 116 from the relaxedstate to a tensioned state causes the fluid collection assembly 101 tobend towards the distal surface 106. For instance, when the tensioningelement 116 is positioned closer to the distal surface 106, the fluidcollection assembly 101 may exhibit a first shape that is curved whenthe tensioning element 116 is in a relaxed state with the proximalsurface 104 thereof forming a concave surface. Switching the tensioningelement 116 to the tensioned state thereof may straighten the fluidcollection assembly 101 (e.g., the second state may be a generallystraight shape).

In an embodiment, as illustrated, a portion of the tensioning element116 is configured to be disposed within the fluid impermeable barrier102. In such an embodiment, the fluid impermeable barrier 102 may defineat least one channel 118 configured to receive the tensioning element116. The channel 118 may allow the fluid impermeable barrier 102 toinsulate the tensioning element 116 from the bodily fluids that arereceived in the chamber 108. In an example, as illustrated, the channel118 may extend along substantially all (e.g., greater than 80%) of alength of the fluid impermeable barrier 102. In such an example, thechannel 118 may define an inlet 120 at or near a proximal end region 122of the fluid impermeable barrier 102. The channel 118 may extend fromthe inlet 120 to or near a distal end region 124. Thus, the tensioningelement 116 extends along all or substantially all of the length of thefluid impermeable barrier 102 thereby allowing the tensioning element116 to affect the shape of the fluid collection assembly 101 alongsubstantially all of the length thereof. In an example, the channel 118may extend through only a portion (e.g., less than 80%, such as lessthan 65%, less than 50%, or less than 35%) of a length of the fluidimpermeable barrier 102. In such an example, the tensioning element 116may affect the shape of the fluid collection assembly 101 along only theportion of the length thereof. It is noted that at least a portion ofthe tensioning element 116 may not disposed in the fluid impermeablebarrier 102, as will be discussed in more detail with regards to FIGS.2A-2E.

In an embodiment, the at least one tensioning element 116 includes aplurality of tensioning elements. In such an embodiment, the fluidimpermeable barrier 102 defines a plurality of channels that areconfigured to receive at least a portion of a corresponding one of theplurality of tensioning elements. The tensioning element 116 may includea plurality of tensioning elements for a variety of reasons. In anexample, as will be discussed in more detail with regards to FIG. 3, theplurality of tensioning elements may allow for greater control of theshape of the fluid collection assembly 101. In an example, the pluralityof tensioning elements may, collectively, increase the strength of thetensioning element 116 and/or may allow the tensioning element 116 tooperate even when one of the plurality of tensioning elements fail orthe fixed portion thereof becomes detached. In an example, asillustrated, the plurality of tensioning elements may allow thetensioning element 116 to avoid obstacles, such as the opening 110. Forinstance, the tensioning element 116 is positioned at the proximal endregion 122 and the distal end region 124 such that, if the tensioningelement 116 only included a single tensioning element 116, thetensioning element 116 would pass across the opening 110 or would haveto deviate to one side of the opening 110. Passing the tensioningelement 116 across the opening 110 may cause the tensioning element 116to contact the individual which may cause discomfort. Further, deviatingthe tensioning element 116 to one side of the opening 110 may cause thefluid collection assembly 101 to bend to the side when the tensioningelement 116 switches between the relaxed and tensioned states. However,selecting the tensioning element 116 to include a plurality oftensioning elements may allow the tensioning element 116 to avoid theopening 110 while preventing the fluid collection assembly 101 frombending to the side when switching the tensioning element 116 betweenthe relaxed and tensioned states thereof. For instance, as best shown inFIGS. 1C and 1D, the at least one tensioning element 116 may include afirst tensioning element 116 a and a second tensioning element 116 b andthe at least one channel 118 may include a first channel 118 a and asecond channel 118 b configured to receive the first tensioning element116 a and the second tensioning element 116 b, respectively. The firstchannel 118 a may extend along one side of the opening 110 when thesecond channel 118 b extends along the opposing side of the opening 110thus preventing the first and second tensioning elements 116 a, 116 bfrom extending across the opening 110. Further, applying a tensile forceto both the first and second tensioning elements 116 a, 116 b mayprevent the fluid collection assembly 101 from bending to either theside.

The fluid collection assembly 101 may exhibit any suitable shape whenthe fluid collection assembly 101 exhibits the first shape (FIG. 1A) andthe second shape (FIG. 1B). In an example, as illustrated, the fluidcollection assembly 101 exhibits a generally straight shape when thefluid collection assembly 101 exhibits the first shape and a generallycurved shape when the fluid collection assembly 101 exhibits the secondshape. As used herein, a generally curved shape may refer to a portionof an arc of a generally circular shape, a generally oval shape, agenerally ellipsoid shape, a generally parabolic shape, any other curvedshape, or combinations thereof. In an example, the fluid collectionassembly 101 exhibits a generally curved shape when the fluid collectionassembly 101 exhibits the first shape and a generally straight shapewhen the fluid collection assembly exhibits the second shape. In anexample, the fluid collection assembly 101 may exhibit a first generallycurved shape when the fluid collection assembly 101 exhibits the firstshape and a second generally curved shape when the fluid collectionassembly 101 exhibits the second shape. In such an example, the firstand second generally curved shapes are different. For instance, thefirst shape may exhibit an average radius of curvature that is greaterthan or less than the average radius of curvature of the second shapeand/or the first shape may be an arc of a different curved shape thanthe second shape.

As previously discussed, the fluid collection assembly 101 may exhibitthe first shape when the tensioning element 116 is in the relaxed stateand the second shape when the tensioning element 116 is in the tensionedstate. It is also noted that the shape of the fluid collection assembly101 may vary depending on the magnitude of the tensile force that isapplied to the tensioning element 116. For example, the fluid collectionassembly 101 may exhibit a first shape when the tensioning element 116is in a relaxed state, a second shape when the tensioning element 116has a first tensile force applied thereto, and a third shape when thetensioning element 116 has a second tensile force applied thereto thatis different in magnitude than the first tensile force. The first,second, and third shapes of the fluid collection assembly 101 are eachdifferent. When the second tensile force is less than the first tensileforce, the third shape of the fluid collection assembly 101 may be moresimilar to the first shape than the second shape. When the secondtensile force is greater than the first tensile force, the second shapeof the fluid collection assembly 101 may be more similar to the firstshape than the third shape.

The fluid collection system 100 may include at least one locking device132. The locking device 132 is configured to receive the tensioningelement 116. The locking device 132 is also configured to at least oneof apply the tensile force to the tensioning element 116 or maintain theapplication of the tensile force to the tensioning element 116. Thelocking device 132 may include, for example, a ratchet-type device (FIG.4A), a sliding device that moves along a component of the fluidcollection system 100 (FIG. 34), tape (FIG. 4C), a spring, clamp, a hookthe tensioning element 116 may be tied to, or any other deviceconfigured to at least one of apply or maintain the tensile force to thetensioning element 116. To facilitate the operation of the lockingdevice 132, the locking device 132 exhibits a fixed position relative tothe fluid collection assembly 101. For example, the locking device 132may be unable to consistently apply and/or maintain the tensile force onthe tensioning element 116 if, in response to the tensile force, thelocking device 132 moves closer to the fluid collection assembly 101and/or vice versa.

The locking device 132 may have any suitable location relative to thefluid collection assembly 101. The locking device 132 may be locatednear the inlet 120 to minimize a length of the tensioning element 116.In an example, as illustrated, the locking device 132 may be located onthe conduit 128 at or near the fluid outlet 112 since (as illustrated)the inlet 120 is near the inlet 120 and the conduit 128 may exhibitsufficient rigidity to prevent the locking device 132 moving closer tothe fluid collection assembly 101 when a tensile force is applied to thetensioning element 116. In an example, the locking device 132 may belocated on the fluid impermeable barrier 102 at or near the inlet 120.In an example, the locking device 132 may be at least partially disposedin the fluid collection assembly 101, such as at least partiallydisposed in the chamber 108. In an example, the locking device 132 maybe disposed on the patient using the fluid collection assembly 101 or onan item of furniture adjacent to the individual (e.g., a bed, anightstand, a chair, a vacuum source, a fluid storage container, etc.).

As previously discussed, the fluid collection assembly 101 includes afluid impermeable barrier 102. The fluid impermeable barrier 102 may beformed of any suitable fluid imporous material(s), such as a fluidimpermeable polymer (e.g., silicone, polypropylene, polyethylene,polyethylene terephthalate, neoprene, a polycarbonate, etc.), a metalfilm, natural rubber, another suitable material, or combinationsthereof. The fluid impermeable barrier 102 substantially prevents thebodily fluids from passing through the fluid impermeable barrier 102. Inan example, the fluid impermeable barrier 102 may be air permeable andfluid impermeable. In such an example, the fluid impermeable barrier 102may be formed of a hydrophobic material that defines a plurality ofpores. At least a surface of the fluid impermeable barrier 102 that maycontact the patient may be formed from a soft and/or smooth material(e.g., silicone), thereby reducing chaffing. In an embodiment, the fluidimpermeable barrier 102 may be formed from a flexible material, such assilicone, which allows the fluid impermeable barrier 102 to be bent intoa shape that conforms the anatomy of the patient. Further, as shown inFIGS. 1A and 1B, forming the fluid impermeable barrier 102 from aflexible material allows the fluid impermeable barrier 102 toaccommodate the shape and/or size causes by switching the tensioningelement 116 between the relaxed and tensioned states thereof.

In some examples, the fluid impermeable barrier 102 may be tubular(ignoring the opening 110), such as substantially cylindrical (asshown), oblong, prismatic, or flattened tubes. During use, the outersurface (e.g., at least a portion of one or more of the proximal surface104, the distal surface 106, or the lateral surface 130) of the fluidimpermeable barrier 102 may contact the patient. The fluid impermeablebarrier 102 may be sized and shaped to fit in the gluteal cleft betweenthe legs of a female user.

The opening 110 provides an ingress route for fluids to enter thechamber 108. The opening 110 may be defined by the proximal surface 104of the fluid impermeable barrier 102. For example, the opening 110 isformed in and extends through the fluid impermeable barrier 102, fromthe proximal surface 104 to an inner surface 134 of the fluidimpermeable barrier 102, thereby enabling bodily fluids to enter thechamber 108 from outside of the fluid collection assembly 101. Theopening 110 may be an elongated hole in the fluid impermeable barrier102. For example, the opening 110 may be defined as a cut-out in thefluid impermeable barrier 102. The opening 110 may be located and shapedto be positioned adjacent to a female urethral opening.

The fluid collection assembly 101 may be positioned proximate to thefemale urethral opening and urine or other bodily fluids may enter thechamber 108 of the fluid collection assembly 101 via the opening 110.The fluid collection assembly 101 is configured to receive the bodilyfluids into the chamber 108 via the opening 110. When in use, theopening 110 may have an elongated shape that extends from a firstlocation below the urethral opening (e.g., at or near the anus or thevaginal opening) to a second location above the urethral opening (e.g.,at or near the top of the vaginal opening or the mons pubis).

The opening 110 may have an elongated shape because the space betweenthe legs of a female is relatively small when the legs of the female areclosed, thereby only permitting the flow of the bodily fluids along apath that corresponds to the elongated shape of the opening 110 (e.g.,longitudinally extending opening). The opening 110 in the fluidimpermeable barrier 102 may exhibit a length measured along thelongitudinal axis of the fluid collection assembly 101 that may be atleast about 10% of the length of the fluid collection assembly 101, suchas about 25% to about 50%, about 40% to about 60%, about 50% to about75%, about 65% to about 85%, or about 75% to about 95% of the length ofthe fluid collection assembly 101.

The opening 110 in the fluid impermeable barrier 102 may exhibit a widthmeasured transverse to the longitudinal axis of the fluid collectionassembly 101 that may be at least about 10% of the circumference of thefluid collection assembly 101, such as about 25% to about 50%, about 40%to about 60%, about 50% to about 75%, about 65% to about 85%, or about75% to about 100% of the circumference of the fluid collection assembly101. The opening 110 may exhibit a width that is greater than 50% of thecircumference of the fluid collection assembly 101 since the vacuum(e.g., suction) through the conduit 128 pulls the fluid through theporous material 114 and into the conduit 128.

In some examples, the opening 110 may be vertically oriented (e.g.,having a major axis parallel to the longitudinal axis of the fluidcollection assembly 101). In some examples (not shown), the opening 110may be horizontally oriented (e.g., having a major axis perpendicular tothe longitudinal axis of the fluid collection assembly 101). In anexample, the fluid impermeable barrier 102 may be configured to beattached to the patient, such as adhesively attached (e.g., with ahydrogel adhesive) to the patient. According to an example, a suitableadhesive is a hydrogel layer.

As previously discussed, the fluid impermeable barrier 102 may definefluid outlet 112 configured to remove bodily fluids from the chamber108. The fluid outlet 112 is distinct from the opening 110. In someexamples, the fluid outlet 112 is sized to receive the conduit 128. Theconduit 128 may be disposed in the chamber 108 via the fluid outlet 112.The fluid outlet 112 may be sized and shaped to form an at leastsubstantially fluid tight seal against the conduit 128 or the at leastone tube substantially preventing the bodily fluids from escaping thechamber 108.

The fluid impermeable barrier 102 may include markings thereon, such asone or more markings to aid a user in aligning the fluid collectionassembly 101 on the patient. For example, a line on the fluidimpermeable barrier 102 (e.g., opposite the opening 110) may allow ahealthcare professional to align the opening 110 over the urethralopening of the patient. In examples, the markings may include one ormore of alignment guide or an orientation indicator, such as a stripe orhashes. Such markings may be positioned to align the fluid collectionassembly 101 to one or more anatomical features such as a pubic bone,etc.

As previously discussed, the fluid collection assembly 101 includesporous material 114 disposed in the chamber 108. The porous material 114may cover at least a portion (e.g., all) of the opening 110. The porousmaterial 114 is exposed to the environment outside of the chamber 108through the opening 110. The permeable properties referred to herein maybe wicking, capillary action, absorption, diffusion, or other similarproperties or processes, and are referred to herein as “permeable”and/or “porous.” The porous material 114 may also wick the bodily fluidsgenerally towards an interior of the chamber 108, as discussed in moredetail below. The porous material 114 may include one or more of a fluidpermeable membrane 136 or a fluid permeable support 138.

In an embodiment, at least a portion of the porous material 114 may be awicking material configured to wick the bodily fluids away from theopening 110, thereby preventing bodily fluids from escaping the chamber108. The wicking material may not include absorption of the bodilyfluids into the wicking material. Put another way, substantially noabsorption of the bodily fluids into the wicking material may take placeafter the wicking material is exposed to the bodily fluids. While noabsorption is desired, the term “substantially no absorption” may allowfor nominal amounts of absorption of the bodily fluids into the wickingmaterial (e.g., absorbency), such as about 30 wt % of the dry weight ofthe wicking material, about 20 wt %, about 15 wt %, about 10 wt %, about7 wt %, about 5 wt %, about 3 wt %, about 2 wt %, about 1 wt %, or about0.5 wt % of the dry weight of the wicking material. In an embodiment,the porous material 114 may be at least one of an absorbent material oradsorbent material instead of or in addition to being a wickingmaterial.

The fluid collection assembly 101 may include the fluid permeablemembrane 136 disposed in the chamber 108. The fluid permeable membrane136 may cover at least a portion (e.g., all) of the opening 110. Thefluid permeable membrane 136 may be composed to pull/push the bodilyfluids away from the opening 110, thereby promoting fluid flow into thechamber 108, prevent fluid remaining on the vulva of the patient, andpreventing the bodily fluids from escaping the chamber 108.

The fluid permeable membrane 136 may include any material that may bepermeable to the bodily fluids. For example, the fluid permeablemembrane 136 may include fabric, such as a gauze (e.g., a silk, linen,or cotton gauze), another soft fabric, or another smooth fabric. Formingthe fluid permeable membrane 136 from gauze, soft fabric, and/or smoothfabric may reduce chaffing caused by the fluid collection assembly 101and makes wearing the fluid collection assembly more comfortable. In anembodiment, the fluid permeable membrane 136 may define a plurality ofperforations or may be continuous (e.g., does not define perforations).

The fluid collection assembly 101 may include the fluid permeablesupport 138 disposed in the chamber 108. The fluid permeable support 138is configured to support the fluid permeable membrane 136 and maintainthe shape of the chamber 108 since the fluid impermeable barrier 102 andthe fluid permeable membrane 136 may be formed from a relativelyfoldable, flimsy, or otherwise easily deformable material. For example,the fluid permeable support 138 may be positioned so the fluid permeablemembrane 136 is disposed between the fluid permeable support 138 and thefluid impermeable barrier 102. The fluid permeable support 138 maysupport and maintain the position of the fluid permeable membrane 136and the shape of the chamber 108. The fluid permeable support 138 mayinclude any material that may be permeable to the bodily fluids, such asany of the fluid permeable membrane 136 materials disclosed above. Forexample, the fluid permeable membrane 136 material(s) may be utilized ina more dense or rigid form than in the fluid permeable membrane 136 whenused as the fluid permeable support 138. The fluid permeable support 138may be formed from any fluid porous material that is less deformablethan the fluid permeable membrane 136. For example, the fluid permeablesupport 138 may include a porous polymer (e.g., nylon, polyester,polyurethane, polyethylene, polypropylene, etc.) structure (e.g., spunfibers such as spun nylon fibers) or a foam (e.g., an open cell foam).In some examples, the fluid permeable support 138 may be formed from anatural material, such as cotton, wool, silk, or combinations thereof.In such examples, the material may have a coating to prevent or limitabsorption of the bodily fluids into the material, such as a waterrepellent coating. In some examples, the fluid permeable support 138 maybe formed from fabric, felt, gauze, or combinations thereof.

In some examples, the fluid permeable membrane 136 may be omitted. Forexample, the porous material 114 may include only the fluid permeablesupport 138. In some examples, the fluid permeable support 138 may beoptionally omitted from the fluid collection assembly 101 and the porousmaterial 114 may only include the fluid permeable membrane 136.

In an embodiment, the fluid permeable membrane 136 and/or the fluidpermeable support 138 are wicking materials. In such an embodiment, thefluid permeable support 138 may have a greater ability to wick thebodily fluids than the fluid permeable membrane 136. In some examples,the wicking ability of the fluid permeable support 138 and the fluidpermeable membrane 136 may be substantially the same. In an embodiment,the fluid permeable membrane 136 and/or the fluid permeable support 138are non-wicking materials (e.g., absorbent and/or adsorbent materials).

In an embodiment, not shown, the fluid permeable membrane 136 and thefluid permeable support 138 may at least substantially completely fillthe portions of the chamber 108 not occupied by the conduit 128. In anembodiment, as shown in FIG. 1D, the fluid permeable membrane 136 andthe fluid permeable support 138 may not substantially completely fillthe portions of the chamber 108 not occupied by the conduit 128. In suchan embodiment, the fluid collection assembly 101 includes the fluidreservoir 140 disposed in the chamber 108.

The fluid reservoir 140 is a substantially unoccupied portion of thechamber 108. The fluid reservoir 140 may be defined between at least thefluid impermeable barrier 102 and at least one of the fluid permeablemembrane 136 or the fluid permeable support 138. The bodily fluids inthe chamber 108 may flow through the fluid permeable membrane 136 and/orfluid permeable support 138 to the fluid reservoir 140. The fluidreservoir 140 may retain of the bodily fluids. The bodily fluids in thechamber 108 may flow through the fluid permeable membrane 136 and/orfluid permeable support 138 and, optionally, to the fluid reservoir 140.The fluid impermeable barrier 102 may retain the bodily fluids in thefluid reservoir 140. The fluid reservoir 140 may be in a portion of thechamber 108 designed to be in a gravimetrically low point of the fluidcollection assembly 101 when the fluid collection assembly 101 is worn.

The fluid collection systems disclosed herein may include the tensioningelements positioned in locations of the fluid collection assembly otherthan disposing the tensioning elements within the fluid impermeablebarrier. FIGS. 2A-2E are cross-sectional schematics of fluid collectionsystems having at least one tensioning element positioned at differentlocations of the fluid collection assembly, according to differentembodiments. Except as otherwise disclosed herein, the fluid collectionsystems illustrated in FIGS. 2A-2E are the same or substantially similarto any of the fluid collection systems disclosed herein. For example,the fluid collection systems includes a fluid collection assembly and atleast one tensioning element at least partially disposed in the fluidcollection assembly. The fluid collection assembly includes a fluidimpermeable at least barrier defining a chamber, at least one opening.and a fluid outlet. The fluid collection assembly also includes at leastone porous material disposed in the chamber.

Referring to FIG. 2A, the fluid collection system 200 a includes a fluidcollection assembly 201 a and at least one tensioning element 216 a. Thefluid collection assembly 201 a includes a fluid impermeable barrier 202a defining a chamber 208 a and at least one porous material 214 adisposed in the chamber 208 a. At least a portion of the tensioningelement 216 a is positioned between the fluid impermeable barrier 202 aand the porous material 214 a. Thus, the fluid impermeable barrier 202 amay separate the tensioning element 216 a from the patient which maymake the fluid collection system 200 a more comfortable to use than ifthe tensioning element 216 s contacted the patient.

Similar to any of the fluid collection systems disclosed herein, the atleast one tensioning element 216 a may include a plurality of tensioningelements, such as a first tensioning element 216 a′ and a secondtensioning element 216 a″. The first tensioning element 216 a′ may bepositioned to one side of the opening 210 a while the second tensioningelement 216 a″ may be positioned on the other side of the opening 210 a.Thus, similar to the first and second tensioning elements 116 a, 116 bof FIGS. 1C and 1D, the first and second tensioning elements 216 a′, 216a″ may not extend across the opening 210 a.

In an embodiment, the fluid collection assembly 201 a may include one ormore braces 242 a. The braces 242 a are attached to and extend betweenat least a portion of the tensioning element 216 a and at least aportion of the fluid impermeable barrier 202 a or the porous material214 a. The braces 242 a may prevent the tensioning element 216 a frommoving from a location between the fluid impermeable barrier 202 a andthe porous material 214 a to a location that allows the tensioningelement 216 a to extend across the opening 210 a. In an example, thebraces 242 a may be strands (e.g., wires, strips of material, etc.) thatextend from and are fixedly attached to at least a portion of thetensioning element 216 a and at least one of the fluid impermeablebarrier 202 a or the porous material 210 a. In such an example, thebraces 242 a may be elastic, thereby allowing the braces 242 a tostretch when the tensioning element 216 a switches between the relaxedand tensioned states thereof. In an example, the braces 242 a may looparound tensioning element 216 a forming a generally U-shape (e.g., thefluid impermeable barrier 202 a or the porous material 210 a is attachedto the terminal ends of and closes the opening of the U-shape), agenerally P-shape, or O-shape. The U-, P-, or O-shape of the braces 242a may form a passageway in which a portion of the tensioning element 216a may be disposed. The passageway may be configured to allow thetensioning element 216 a to move therein, such as move therein when thetensioning element 216 a switches between the relaxed and tensionedstates thereof. The braces 242 a may be formed from fabric, one or moremetals, one or more polymers, or combinations thereof.

Referring to FIG. 2B, the fluid collection system 200 b includes a fluidcollection assembly 201 b and at least one tensioning element 216 b. Thefluid collection assembly 201 b includes a fluid impermeable barrier 202b and at least one porous material 214 b. At least a portion of thetensioning element 216 b is positioned in the fluid collection assembly201 b to be within the porous material 214 b. For example, the porousmaterial 214 b may include a fluid permeable membrane 236 b and a fluidpermeable support 238 b. In such an example, the tensioning element 216b may be positioned between the fluid permeable membrane 236 b and thefluid permeable support 238 b. The tensioning element 216 b may bepositioned within the porous material 214 b, for example, using a dualextrusion technique or threading the tensioning element 216 b betweenthe fluid permeable membrane 236 b and the fluid permeable support 238b.

In an embodiment, as illustrated, that tensioning element 216 b mayextend directly beneath the opening 210 b since the tensioning element216 b is spaced from the opening 210 b by a portion of the porousmaterial 214 b (e.g., the fluid permeable membrane 236 b prevents thetensioning element 216 b from contacting the individual). In anembodiment, the tensioning element 216 b may include a plurality oftensioning elements.

Referring to FIG. 2C, the fluid collection system 200 c includes a fluidcollection assembly 201 c and at least one tensioning element 216 c. Thefluid collection assembly 201 c includes a fluid impermeable barrier 202c, at least one porous material 214 c, and a conduit 228 c. At least aportion of the tensioning element 216 c is positioned in the fluidcollection assembly 201 c to be between the porous material 214 c andthe conduit 228 c. In an embodiment, as illustrated, that tensioningelement 216 c may extend directly beneath the opening 210 c since thetensioning element 216 c is spaced from the opening 210 c by the porousmaterial 214 c. In an embodiment, the tensioning element 216 c mayinclude a plurality of tensioning elements.

Referring to FIG. 2D, the fluid collection system 200 d includes a fluidcollection assembly 201 d and at least one tensioning element 216 d. Thefluid collection assembly 201 d includes a fluid impermeable barrier 202d, at least one porous material 214 d, and a conduit 228 d. At least aportion of the tensioning element 216 d is positioned in the fluidcollection assembly 201 d to be within the conduit 228 d. The walls ofthe conduit 228 d may define at least one channel therein. Thetensioning element 216 d may be disposed within the channels. Thetensioning element 216 d may be disposed in the channel, for example,using a dual extrusion technique. In an embodiment, as illustrated, thattensioning element 216 d may extend directly beneath the opening 210 dsince the tensioning element 216 d is spaced from the opening 210 d bythe porous material 214 d. In an embodiment, the tensioning element 216d may include a plurality of tensioning elements.

Referring to FIG. 2E, the fluid collection system 200 e includes a fluidcollection assembly 201 e and at least one tensioning element 216 e. Thefluid collection assembly 201 e includes a fluid impermeable barrier 202e, at least one porous material 214 e, and a conduit 228 e. At least aportion of the tensioning element 216 e is positioned in the fluidcollection assembly 201 e to be within a passageways 244 e defined bythe conduit 228 e.

It is noted that any of the fluid collection systems may include atleast one tensioning elements that is positioned in two or more of thelocations of the fluid collection assembly disclosed herein. In anexample, at least two of a portion of the tensioning element may bedisposed in the fluid impermeable barrier (as shown in FIGS. 1C and 1D),a portion of the tensioning element may be positioned between the fluidimpermeable barrier and the porous material, within the porous material,between the conduit and the porous material, within a channel defined bythe conduit, or with a passageway defined by the conduit. In an example,the at least one tensioning element may include a plurality oftensioning elements and at least two of the tensioning elements arepositioned in different locations of the fluid collection assembly.

As previously discussed, the fluid collection systems disclosed hereinmay include a plurality of tensioning elements. However, the pluralityof tensioning elements may be configured to control the shape ofdifferent portions of the fluid collection assembly. For example, FIG. 3is a cross-sectional schematics of a fluid collection system 300,according to an embodiment. Except as otherwise disclosed herein, thefluid collection system 300 is the same or substantially similar to anyof the fluid collection systems disclosed herein. For example, the fluidcollection system includes a fluid collection assembly 301, a pluralityof tensioning elements, a conduit 328, and at least one locking device332. The fluid collection assembly 301 may include a fluid impermeablebarrier and a porous material, as previously discussed herein. Forillustrative purposes, the individual components of the fluid collectionassembly 301 are not illustrated and the exterior of the fluidcollection assembly 301 is illustrated using dashed lines.

As previously discussed, the fluid collection assembly 301 includes aplurality of tensioning elements. In the illustrated embodiment, thefluid collection assembly 301 is illustrated as including a firsttensioning element 316 a, a second tensioning element 316 b, and a thirdtensioning element 316 c. However, it is noted that the fluid collectionassembly 301 may include only two tensioning elements or four or moretensioning elements and that the same principles discussed herein applyregardless of the number of tensioning elements.

Each of the first, second, and third tensioning elements 316 a, 316 b,316 c include fixed portions 326 a, 326 b, 326 c, respectively, that areconnected to different portion of the fluid collection assembly 301. Inthe illustrated embodiment, the first, second, and third fixed portions326 a, 326 b, 326 c are attached to the conduit 328. However, aspreviously discussed, the fixed portions 326 a, 326 b, 326 c may beattached to other components of the fluid collection assembly 301, suchas the fluid impermeable barrier or the porous material. The first fixedportion 326 a is attached to a first location of the fluid collectionassembly 301, the second fixed portion 326 b is attached to a secondlocation of the fluid collection assembly 301 that is closer to thelocking device 332 than the first location, and the second fixed portion326 c is attached to a third location of the fluid collection assembly301 that is closer to the locking device 332 than the first and secondlocations.

The first tensioning element 316 a is configured to change the shape ofa first region 346 a of the fluid collection assembly 301 that extendsgenerally between the first location and an inlet (e.g., inlet 120 ofFIGS. 1A, 1B, and 1D) through which the first tensioning element 316 aenters the fluid collection assembly 301. The second tensioning element316 b is configured to change the shape of a second region 346 b of thefluid collection assembly 301 that generally extends between the secondlocation and an inlet through which the second tensioning element 316 benters the fluid collection assembly 301. The third tensioning element316 c is configured to change the shape of a third region 346 c of thefluid collection assembly 301 that generally extends between the thirdlocation and an inlet through which the third tensioning element 316 centers the fluid collection assembly 301. It is noted that the first,second, and third portions 346 a, 346 b, 346 c of the fluid collectionassembly overlap and that the inlet through which the first, second, andthird tensioning elements 316 a, 316 b, 316 c enter the fluid collectionassembly 301 may be the same inlet or different inlets.

The fluid collection assembly 301 may exhibit a first shape when each ofthe first, second, and third tensioning elements 316 a, 316 b, 316 c arein a relaxed shape. The shape of the fluid collection assembly 301 maybe controlled by selectively switching one or more of the first, second,and third tensioning elements 316 a, 316 b, 316 c to the tensionedstates thereof and varying the magnitude of the tensile force appliedthereto. In an embodiment, the fluid collection assembly 301 is switchedfrom a first shape to a second shape by switching the first tensioningelement 316 a from a relaxed state to a tensioned state thereof. Thesecond shape includes modifying the shape of the first region 346 a ofthe fluid collection assembly 301. The shape of the fluid collectionassembly 301 may be further changed by selectively switching one or moreof the second or third tensioning elements 316 b, 316 c to the tensionedstates thereof. In an example, the fluid collection assembly 301 may beswitched from the second shape to a third shape by switching the secondtensioning element 316 b to the tensioned state thereof which changesthe shape of the second region 346 b of the fluid collection assembly301 but may not change the shape of the portion of the first region 346a that does not overlap the second region 346 b. In an example, thefluid collection assembly 301 may be switched from the second shape orthe third shape to a fourth shape by switching the third tensioningelement 316 c to the tensioned state thereof which changes the shape ofthe third region 346 c of the fluid collection assembly 301 but may notchange the shape of the portions of the first region 346 a and secondregion 346 b that do not overlap the third region 346 c. In anembodiment, the fluid collection assembly 301 is switched from the firstshape to a fifth shape by switching the second tensioning element 316 bfrom a relaxed state to a tensioned state thereof. The fifth shapeincludes modifying the shape of the second region 346 b of the fluidcollection assembly 301 but may not affect the portions of the firstregion 346 a that does not overlap with the second region 346 b. Thefluid collection assembly 301 may be switched from the fifth shape to asixth shape by switching the third tensioning element 316 c from arelaxed state to a tensioned state thereof which changes the shape ofthe third region 346 c of the fluid collection assembly 301 but may notchanges the shape of the portions of the first region 346 a and thesecond region 346 c that do not overlap the second region 346 c. In anembodiment, the fluid collection assembly 301 may switch from the firststate to a seventh shape by switching third tensioning element 316 c tothe tensioned state thereof. In such an embodiment, the third tensioningelement 316 c changes the shape of the third region 346 c but may notsubstantially change the shape of the portions of the first region 346 aand the second region 346 b that do not overlap with the third region346 c. It is noted that these embodiments are examples provided forillustrative purposes only and should not be construed as limiting theoperation of the fluid collection system 300. Further, it is noted thatthe first, second, and/or third tensioning elements 316 a, 316 b, 316 cmay be switched from their respective relaxed states to their respectivetensioned states in different orders than provided above, withoutlimitation, and still obtain the same or substantially the same result.For example, the fluid collection assembly 301 may switch from the firstshape to the third shape by switching one or more of the secondtensioning element 316 b or the third tensioning element 316 c to thetensioned state thereof before or substantially simultaneously withswitching the first tensioning element 316 a to the tensioned statethereof.

As previously indicated, FIGS. 4A-4C are isometric views of differentlocking devices that may be used in any of the fluid collection systemsdisclosed herein, according to different embodiments. Referring to FIG.4A, the locking device 432 a is a ratchet-type locking device. Forexample, the locking device 432 a is configured to selectively allow thetensioning element 416 a to be drawn into the locking device 432 aand/or selectively allow the tensioning element 416 a to be withdrawnfrom the locking device 432 a. In other words, the locking device 432 amay be configured to restrict the movement of the tensioning element 416a to one direction, either into or out of the locking device 432 a.

The locking device 432 a may include a first actuator 448 that isconfigured to allow a user to select whether the locking device 432 aallows the tensioning element 416 a to be drawn into the locking device432 a and/or allows the tensioning element 416 a to be withdrawn fromthe locking device 432 a. For example, the first actuator 448 may beconfigured to switch from a first state to a second state, wherein thefirst actuator 448 allow the locking device 432 a to draw the tensioningelement 416 a into the locking device when the first actuator 448 is inthe first state and to withdraw the tensioning element 416 a from thelocking device when the first actuator 448 is in the second state. Thelocking device 432 a may also include a second actuator 450 that allowsa user to draw the tensioning element 416 a into the locking device 432a and/or out of the locking device 432 a. The first and second actuators448, 450 may include any suitable actuators. For example, in theillustrated embodiment, the first and second actuators 448, 450 are alever (e.g., switch) and a knob, respectively. Alternatively, one ormore of the first or second actuators 448, 450 may include button(s),handle(s), or any other actuator(s).

In a particular example, the locking device 432 a may include a spool(not shown, in interior) that is configured to receive the tensioningelement 416 a. The first actuator 448 may be configured to restrictrotation of the spool to a single direction. For instance, the firstactuator 448 may only allow the spool to rotate in a direction thatpulls the tensioning element 416 a onto the spool when the firstactuator 448 is in a first state. Further, the first actuator 448 mayonly allow the spool to rotate in a direction that allows the tensioningelement 416 a to leave the spool when the first actuator 448 is in asecond state. The second actuator 450 is connected to the spool and isconfigured to rotate the spool.

Referring to FIG. 4B, the locking device 432 b is a sliding-type lockingdevice. The locking device 432 b defines a passageway (not shown,obscured) that is configured to receive the conduit 428 b. The kineticfriction between the surface of the locking device 432 b that definesthe passageway and the conduit 428 b maintains the position of thelocking device 432 b on the conduit 428 b, even when the locking device432 b applies a tensile force to the tensioning element 416 b, up to athreshold magnitude. However, manipulation of the locking device 432 bby a user may be sufficient to overcome kinetic friction between thesurface of the locking device 432 b that defines the passageway and theconduit 428 b. For example, the user may switch the tensioning element416 b from a relaxed state to a tensioned state or increase a magnitudeof a tensile force applied to the tensioning element 416 b by moving thelocking device 432 b away from the fluid collection assembly 401 b.Further, the user may switch the tensioning element 416 b from atensioned state to a relaxed state or decrease a magnitude of a tensileforce applied to the tensioning element 416 b by moving the lockingdevice 432 b towards the fluid collection assembly 401 b.

Referring to FIG. 4C, the locking device 432 c is tape. A user may pullor release the tensioning element 416 c to selectively switch thelocking device 432 c from a relaxed state to a tensioned state, atensioned state to a relaxed state, or to control a magnitude of thetensile force applied to the tensioning element 416 c. Once the userstops pulling or releasing the tensioning element 416 c, the lockingdevice 432 c may be used to secure a position of the tensioning element416 c such that the state of the tensioning element 416 c and/or themagnitude of the tensile force applied to the tensioning element 416 cmaintains unchanged. The locking device 432 c may be removed if the userwants to further pull or release the tensioning element 416 c.

As previously discussed, the fluid collection systems disclosed hereinmay include a plurality of tensioning element. In an embodiment, thefluid collection systems may include a plurality of locking devices.Each of the locking devices may receive at least one of the plurality ofthe tensioning elements. The plurality of locking devices may be thesame or different. In an embodiment, the fluid collection systems mayinclude a single locking device that receives each of the plurality oftensioning elements.

FIG. 5 is a block diagram of a system 500 for fluid collection,according to an embodiment. The system 500 includes a fluid collectionassembly 501, a fluid storage container 507, and a vacuum source 509.The fluid collection assembly 501, the fluid storage container 507, andthe vacuum source 509 may be fluidly coupled to each other via one ormore conduits 528. For example, fluid collection assembly 501 may beoperably coupled to one or more of the fluid storage container 507 orthe vacuum source 509 via the conduit 528. Fluid (e.g., urine or otherbodily fluids) collected in the fluid collection assembly 501 may beremoved from the fluid collection assembly 501 via the conduit 528 whichprotrudes into the fluid collection assembly 501. For example, an inletof the conduit 528 may extend into the fluid collection assembly 501,such as to a fluid reservoir therein. The outlet of the conduit 528 mayextend into the fluid collection assembly 501 or the vacuum source 509.Suction force may be introduced into the chamber of the fluid collectionassembly 501 via the inlet of the conduit 528 responsive to suction(e.g., vacuum) force applied at the outlet of the conduit 528.

The suction force may be applied to the outlet of the conduit 528 by thevacuum source 509 either directly or indirectly. The suction force maybe applied indirectly via the fluid storage container 507. For example,the outlet of the conduit 528 may be disposed within the fluid storagecontainer 507 and an additional conduit 528 may extend from the fluidstorage container 507 to the vacuum source 509. Accordingly, the vacuumsource 509 may apply suction to the fluid collection assembly 501 viathe fluid storage container 507. The suction force may be applieddirectly via the vacuum source 509. For example, the outlet of theconduit 528 may be disposed within the vacuum source 509. An additionalconduit 528 may extend from the vacuum source 509 to a point outside ofthe fluid collection assembly 501, such as to the fluid storagecontainer 507. In such examples, the vacuum source 509 may be disposedbetween the fluid collection assembly 501 and the fluid storagecontainer 507.

The fluid collection assembly 501 may be similar or identical to any ofthe fluid collection assemblies disclosed herein in one or more aspects.The fluid collection assembly 501 may be shaped and sized to bepositioned adjacent to a female urethral opening. For example, the fluidcollection assembly 501 may include a fluid impermeable barrier at leastpartially defining a chamber (e.g., interior region) of the fluidcollection assembly 501. The fluid impermeable barrier also defines atleast one opening extending therethrough from the external environment.The opening may be positioned adjacent to the female urethral opening.The fluid collection assembly 501 may include porous material disposedin the chamber, such as one or more of a fluid permeable support and afluid permeable membrane. The system 500 may include at least onetensioning element (not shown) at least partially disposed in the fluidcollection assembly 501. The conduit 528 may extend into the fluidcollection assembly 501 at a first end (e.g., proximal) region, throughone or more of the fluid impermeable barrier or the porous material to asecond end region of the fluid collection assembly 501. The conduit 528includes an inlet and an outlet, the outlet being fluidly coupled to thefluid storage container and the inlet being positioned in a portion ofthe chamber selected to be at a gravimetrically low point of the fluidcollection assembly when worn.

The fluid storage container 507 is sized and shaped to retain a fluidtherein. The fluid storage container 507 may include a bag (e.g.,drainage bag), a bottle or cup (e.g., collection jar), or any otherenclosed container for storing bodily fluid(s) such as urine. In someexamples, the conduit 528 may extend from the fluid collection assembly501 and attach to the fluid storage container 507 at a first pointtherein. An additional conduit 528 may attach to the fluid storagecontainer 507 at a second point thereon and may extend and attach to thevacuum source 509. Accordingly, a vacuum (e.g., suction) may be drawnthrough fluid collection assembly 501 via the fluid storage container507. Fluid, such as urine, may be drained from the fluid collectionassembly 501 using the vacuum source 509.

The vacuum source 509 may include one or more of a manual vacuum pump,and electric vacuum pump, a diaphragm pump, a centrifugal pump, adisplacement pump, a magnetically driven pump, a peristaltic pump, orany pump configured to produce a vacuum. The vacuum source 509 mayprovide a vacuum or suction to remove fluid from the fluid collectionassembly 501. In some examples, the vacuum source 509 may be powered byone or more of a power cord (e.g., connected to a power socket), one ormore batteries, or even manual power (e.g., a hand operated vacuumpump). In some examples, the vacuum source 509 may be sized and shapedto fit outside of, on, or within the fluid collection assembly 501. Forexample, the vacuum source 509 may include one or more miniaturizedpumps or one or more micro pumps. The vacuum sources 509 disclosedherein may include one or more of a switch, a button, a plug, a remote,or any other device suitable to activate the vacuum source 509.

FIG. 6 is a flow diagram of a method 600 to collect fluid, according toan embodiment. The method 600 of collecting fluid may utilize use any ofthe fluid collection systems disclosed herein. The method 600 mayinclude act 610, which recites “positioning at least one opening of afluid collection assembly adjacent to a female urethral opening.” Act610 may be followed by act 620, which recites “tensioning at least onetensioning element to switch the tensioning element from a relaxed stateto a tensioned state to change a curvature of the fluid collectionassembly.” Act 620 may be followed by act 630, which recites “receivingone or more bodily fluids from the female urethral opening into achamber of the fluid collection assembly.”

Acts 610, 620, 630 of the method 600 are for illustrative purposes. Forexample, the act 610, 620, 630 of the method 600 may be performed indifferent orders, split into multiple acts, modified, supplemented, orcombined. In an example, one or more of the acts 610, 620, 630 of themethod 600 may be omitted from the method 600. Any of the acts 610, 620,or 630 may include using any of the fluid collection assemblies orsystems disclosed herein.

Act 610 recites “positioning at least one opening of a fluid collectionassembly adjacent to a female urethral opening.” The act 610 ofpositioning the opening of a fluid collection assembly adjacent to afemale urethral opening may include utilizing any of the fluidcollection assemblies or systems disclosed herein. In some examples, act610 may include positioning the opening of a fluid collection assemblysuch that the fluid permeable membrane of the female fluid collectionassembly abuts or is positioned proximate to the female urethralopening. In some examples, positioning an opening of a fluid collectionassembly adjacent to a female urethral opening may include positioningthe opening over the female urethral opening, such as positioning alongitudinally extending opening of the fluid collection assembly overthe female urethral opening.

Act 620 recites “tensioning at least one tensioning element to switchthe tensioning element from a relaxed state to a tensioned state tochange a curvature of the fluid collection assembly.” Switching thetensioning element from the relaxed state to the tensioned state mayinclude shaping a female fluid collection assembly to contour to theanatomy around the urethral opening. In some embodiments, switching thetensioning element from the relaxed state to the tensioned state mayinclude forming the (e.g., a longitudinal shape of the) fluid collectionassembly into an arcuate shape conforming to the perineal region of thepatient. For example, switching the tensioning element from the relaxedstate to the tensioned state may include forming the fluid collectionassembly into an arcuate shape conforming to the vaginal and perinealregion of a patient.

Act 630 recites, “receiving one or more bodily fluids from the femaleurethral opening into a chamber of the fluid collection assembly.” Insome examples, receiving bodily fluids from the female urethral openinginto a chamber of the fluid collection assembly includes receiving thebodily fluids through the opening of the fluid collection assembly.Receiving bodily fluids from the female urethral opening into a chamberof the fluid collection assembly may include wicking the bodily fluidsaway from the opening using porous material, such as via a fluidpermeable membrane and a fluid permeable support. Receiving bodilyfluids from the female urethral opening into a chamber of the fluidcollection assembly may include flowing the bodily fluids towards aportion of the chamber that is fluidly coupled to an inlet of a conduitin fluid communication a vacuum source. For instance, receiving bodilyfluids from the female urethral opening into a chamber of the fluidcollection assembly may include flowing the bodily fluids to asubstantially unoccupied portion of the chamber (e.g., a fluidreservoir), to a gravimetrically low point of the chamber, etc., such asvia gravity, wicking, or suction force. In some examples, wicking thebodily fluids into the chamber via the fluid permeable membrane andfluid permeable support may include wicking urine into a fluid reservoirin the fluid collection assembly.

The method 600 may include applying suction with a vacuum sourceeffective to suction the bodily fluids from the chamber via a conduitdisposed therein and fluidly coupled to the vacuum source may includeusing any of the vacuum sources disclosed herein. Applying suction witha vacuum source may include activating the vacuum source (e.g., suctiondevice) in fluid communication with the inlet of the conduit in thefluid collection assembly. In some examples, activating the vacuumsource in fluid communication with the inlet of the conduit in the fluidcollection assembly may include supplying power to the vacuum source byone or more of flipping an on/off switch, pressing a button, pluggingthe vacuum source into a power outlet, putting batteries into the vacuumsource, etc. In some examples, the vacuum source may include a handoperated vacuum pump and applying suction with a vacuum source mayinclude manually operating the hand operated vacuum pump effective tosuction the bodily fluids from the chamber via the conduit disposedtherein that is fluidly coupled to the vacuum source.

In some examples, applying suction with a vacuum source effective tosuction the bodily fluids from the chamber via a conduit disposedtherein and fluidly coupled to the vacuum source may be effective toremove at least some bodily fluids (e.g., urine) from the chamber (e.g.,interior region) of the fluid collection assembly. In some examples,applying suction with a vacuum source effective to suction the bodilyfluids from the chamber via a conduit disposed therein and fluidlycoupled to the vacuum source may be effective to transfer at least someof the bodily fluids from the chamber to a fluid storage container(e.g., a bottle or bag), such as from one or more of a reservoir, fluidpermeable support, or fluid permeable membrane.

In some examples, the vacuum source (e.g., suction device) may bedisposed on or within the fluid collection assembly and applying suctionwith the vacuum source may include activating the vacuum source. In someexamples, the vacuum source may be spaced from the fluid collectionassembly and applying suction with the vacuum source may includeactivating the vacuum source.

In some examples, applying suction with a vacuum source effective tosuction the bodily fluids from the chamber via a conduit disposedtherein and fluidly coupled to the vacuum source may include detectingmoisture in the chamber (e.g., via one or more moisture sensors) andresponsive thereto, activating the vacuum source to provide suction inthe chamber. The control of the vacuum source responsive to the signalsindicating that moisture or a level thereof is present in the chambermay be automatic, such as via a controller (e.g., computer programmed toperform the operation), or may merely provide an indication that a levelof moisture is present that may necessitate removal of fluid from thechamber of the fluid collection assembly. In the latter case, a wearermay receive the indication (e.g., from the controller) and activate thevacuum pump manually.

In an example, the method 600 may include collecting the bodily fluidsthat are removed from the fluid collection assembly, such as into afluid storage container that is spaced from the fluid collectionassembly and fluidly coupled to the conduit. The fluid storage containermay include any of the fluid storage containers disclosed herein.

The fluid collection assemblies disclosed herein are configured tocollect one or more bodily fluids from a female urethral opening.However, it is noted that any of the concepts disclosed herein, such astensioning elements, may be configured to collect one or more bodilyfluids from a male urethral opening (e.g., penis). Examples of fluidcollection assemblies that are configured to collected bodily fluidsfrom a male urethral opening and methods of using such fluid collectionassemblies are disclosed in International Application No. PCT/US20/42262filed on Jul. 14, 2020, U.S. patent application Ser. No. 14/433,773filed on Apr. 3, 2020, and U.S. Provisional Patent Application No.63/047,374 filed on Jul. 2, 2020, the disclosure of each of which isincorporated herein, in its entirety, by this reference.

While various aspects and embodiments have been disclosed herein, otheraspects and embodiments are contemplated. The various aspects andembodiments disclosed herein are for purposes of illustration and arenot intended to be limiting.

Terms of degree (e.g., “about,” “substantially,” “generally,” etc.)indicate structurally or functionally insignificant variations. In anexample, when the term of degree is included with a term indicatingquantity, the term of degree is interpreted to mean±10%, ±5%, or +2% ofthe term indicating quantity. In an example, when the term of degree isused to modify a shape, the term of degree indicates that the shapebeing modified by the term of degree has the appearance of the disclosedshape. For instance, the term of degree may be used to indicate that theshape may have rounded corners instead of sharp corners, curved edgesinstead of straight edges, one or more protrusions extending therefrom,is oblong, is the same as the disclosed shape, etc.

We claim:
 1. A fluid collection system, comprising: a fluid collectionassembly including: a fluid impermeable barrier defining a chamber, atleast one opening, and at least one fluid outlet; at least one porousmaterial disposed in the chamber; and at least one tensioning element atleast partially disposed in the fluid collection assembly, the at leastone tensioning element configured to switch from a relaxed state whenthe at least one tensioning element has substantially no tension forceapplied thereto and a tensioned state when the at least one tensioningelement has a tension force applied thereto; wherein switching the atleast one tensioning element between the relaxed state and the tensionedstate changes a curvature of at least a portion of the fluid collectionassembly.
 2. The fluid collection system of claim 1, wherein the fluidimpermeable barrier includes at least one proximal surface defining theat least one opening and at least one distal surface opposite theproximal surface, and wherein the at least one tensioning element ispositioned closer to the proximal surface than the distal surface. 3.The fluid collection system of claim 1, wherein the at least onetensioning element includes at least one first tensioning element on oneside of the at least one opening and at least one second tensioningelement on an opposite side of the at least one opening.
 4. The fluidcollection system of claim 1, wherein the at least one tensioningelement includes a fixed portion at or near a terminal end of the atleast one tensioning element, the fixed portion fixedly attached to atleast one of the fluid impermeable barrier, the at least one porousmaterial, or a conduit disposed in the chamber.
 5. The fluid collectionsystem of claim 1, wherein the fluid impermeable barrier defines one ormore channels therein, the at least one tensioning element disposed inthe one or more channels.
 6. The fluid collection system of claim 5,wherein the at least one tensioning element includes at least one firsttensioning element and at least one second tensioning element and theone or more channels include at least one first channel on one side ofthe at least one opening and at least one second channel on an oppositeside of the at least one opening, the at least one first tensioningelement disposed in the at least one first channel and the at least onesecond tensioning element disposed in the at least one second channel.7. The fluid collection system of claim 1, wherein the at least onetensioning element is disposed between the fluid impermeable barrier andthe at least one porous material.
 8. The fluid collection system ofclaim 1, wherein the at least one porous material includes a fluidpermeable support and a fluid permeable membrane, and wherein the atleast one tensioning element extends between the fluid permeable supportand the fluid permeable membrane.
 9. The fluid collection system ofclaim 1, further comprising a conduit extending through at least aportion of the chamber.
 10. The fluid collection system of claim 9,wherein the conduit defines at least one channel and the at least onetensioning element is disposed in the channel.
 11. The fluid collectionsystem of claim 9, wherein the conduit defines a passageway configuredto receive one or more bodily fluids, the at least one tensioningelement disposed in the passageway.
 12. The fluid collection system ofclaim 1, wherein the at least one tensioning element is disposed betweenthe conduit and the at least one porous material.
 13. The fluidcollection system of claim 1, wherein the at least one tensioningelement includes one or more wires.
 14. The fluid collection system ofclaim 1, further comprising a locking mechanism configured to maintainthe at least one tensioning element in the tensioned state, the lockingmechanism secured or configured to be secured to a component of thefluid collection assembly.
 15. The fluid collection system of claim 14,wherein the locking mechanism includes a ratchet-type device.
 16. Thefluid collection system of claim 15, wherein the ratchet device isconfigured to selectively pull the at least one tensioning elementtherein or release the at least one tensioning element therefrom. 17.The fluid collection system of claim 14, wherein the locking mechanismincludes a slide attached to the at least one tensioning element, theslide extending at least partially around a conduit extending from thefluid outlet, the slide configured to selectively move along theconduit.
 18. The fluid collection system of claim 14, wherein thelocking mechanism includes tape.
 19. The fluid collection system ofclaim 1, further comprising: a fluid storage container; and a vacuumsource; wherein the chamber of the fluid collection assembly, the fluidstorage container, and the vacuum source are in fluid communication witheach other via one or more conduits.
 20. A method of using a fluidcollection system, the method comprising: positioning at least oneopening of a fluid collection assembly of the fluid collection systemadjacent to a female urethral opening, the fluid collection assemblyincluding: a fluid impermeable barrier defining a chamber, at least oneopening, and at least one fluid outlet; and at least one porous materialdisposed in the chamber; and wherein the fluid collection system furthercomprises at least one tensioning element at least partially disposed inthe fluid collection assembly; and tensioning at least one tensioningelement to switch the tensioning element from a relaxed state to atensioned state to change a curvature of the fluid collection assembly.